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  • Fusion and Opioid-sparing with the Use of Ketorolac in Posterior Thoracolumbar Spinal Fusions: A Prospective Double-blinded Randomized Placebo-Controlled Trial

    Final Number:

    Chad F Claus D.O.; Evan Joseph Lytle DO; Doris Tong MD; Diana Sigler R.Ph; Dominick Lago MD; Matthew Bahoura BA; Amarpal Dosanjh BS; Michael H Lawless BS DO; Dejan Slavnic DO; Jacob Jasinski DO; Robert W McCabe D.O.; Karl Kado MD; Prashant S Kelkar DO; Clifford Houseman DO; Peter L Bono D.O.; Boyd Richards DO; Teck-Mun Soo MD

    Study Design:
    Clinical Trial

    Subject Category:

    Meeting: Section on Disorders of the Spine and Peripheral Nerves Spine Summit 2019

    Introduction: Use of Ketorolac in spinal fusion is limited due to the risk of pseudarthrosis. Recent literature suggested that such an effect could be type- and dose-related. We sought to demonstrate that Ketorolac use was safe with significant opioid-sparing effect and non-inferior fusion rate.

    Methods: This is a prospective, double-blinded, randomized placebo-controlled trial designed according to the 2013 SPIRIT Guidelines. It is a two-arm parallel design with a 1:1 randomization. Over a two-year period under 6 surgeons at two sites, consecutive patients who underwent elective 1-3 level minimally invasive thoracolumbar fusion were screened for inclusion/exclusion. Patients with fusion confounders were excluded. A centralized treatment allocation mechanism and Excel-generated block randomization were used. Patients received a 48-hour scheduled treatment of intravenous Ketorolac (15mg IV Q6H) or saline. We implemented a standardized analgesia regimen using a standardized order set. The primary outcome was fusion rate as evaluated XR/CT using the Suk criteria at 6/12 months by a blinded neuroradiologist. The secondary outcomes were morphine-equivalence (MME) in the first 48h postop and during the hospital stay, NSAIDs-specific perioperative complications, VAS, length of stay, and quality-of-life outcomes at 6/12 months. Univariate analysis was used with p <0.05 considered significant. The sample size was estimated to be 600. This is an interim analysis to evaluate the safety and MME reduction.

    Results: Sixty-nine patients were analyzed. Patient characteristics and operative data were comparable between the groups except EBL (Tables 1&2). No significant difference in fusion was found at 6-month (Table 3). There was a significant reduction in total/48-hour MME and length of stay for the Ketorolac group (Table 4). The only complication was a superficial hematoma in a ketorolac-assigned patient requiring evacuation.

    Conclusions: Ketorolac demonstrated safety, a significant reduction in postoperative opioid use and length of stay when used as part of a multi-modal analgesics regimen after thoracolumbar fusion.

    Patient Care: By demonstrating Ketorolac as a safe adjuvant to opioid pain medication in patients undergoing thoracolumbar fusion we can contribute positively to the growing opioid epidemic and offer an additional safe and effective tool when treating postoperative pain.

    Learning Objectives: By the conclusion of this session, participants should be able to: 1. Describe the importance of Ketorolac’s safety and effect in reducing opioid use in thoracolumbar fusion, 2. Discuss in small groups Ketorolac’s safety in thoracolumbar fusion, its effect on postoperative opioid use, and length of stay, 3. Identify Ketorolac as a safe adjuvant treatment for postoperative pain following thoracolumbar fusion with opioid-sparing effects and comparable fusion rate.

    References: 1. Li Q, Zhang Z, Cai Z. High-dose ketorolac affects adult spinal fusion: a meta-analysis of the effect of perioperative nonsteroidal anti-inflammatory drugs on spinal fusion. Spine 2011;36:E461-468. 2. Jahr JS, Montalvo HM, Holton R, et al. Does ketorolac tromethamine, a new analgesic, decrease postoperative recovery time, narcotic requirements, nausea and/or vomiting, and unscheduled hospital admissions: a retrospective analysis. Acta Anaesthesiol Belg 1993;44:141–7. 3. Li J, Ajiboye RM, Orden MH, et al. The Effect of Ketorolac on Thoracolumbar Posterolateral Fusion: A Systematic Review and Meta-Analysis. Clin Spine Surg 2018;31:65–72. 4. Pradhan BB, Tatsumi RL, Gallina J, et al. Ketorolac and spinal fusion: does the perioperative use of ketorolac really inhibit spinal fusion? Spine 2008;33:2079–82. 5. Reuben SS, Connelly NR, Lurie S, et al. Dose-response of ketorolac as an adjunct to patient-controlled analgesia morphine in patients after spinal fusion surgery. Anesth Analg 1998;87:98–102. 6. Urrutia J, Mardones R, Quezada F. The effect of ketoprophen on lumbar spinal fusion healing in a rabbit model. Laboratory investigation. J Neurosurg Spine 2007;7:631–6. 7. Dimar JR, Ante WA, Zhang YP, et al. The effects of nonsteroidal anti-inflammatory drugs on posterior spinal fusions in the rat. Spine 1996;21:1870–6. 8. Long J, Lewis S, Kuklo T, et al. The effect of cyclooxygenase-2 inhibitors on spinal fusion. J Bone Joint Surg Am 2002;84-A:1763–8. 9. Riew KD, Long J, Rhee J, et al. Time-dependent inhibitory effects of indomethacin on spinal fusion. J Bone Joint Surg Am 2003;85-A:632–4. 10. Gajraj NM. The effect of cyclooxygenase-2 inhibitors on bone healing. Reg Anesth Pain Med 2003;28:456–65. 11. Reuben SS, Ablett D, Kaye R. High dose nonsteroidal anti-inflammatory drugs compromise spinal fusion. Can J Anaesth J Can Anesth 2005;52:506–12. 12. Sucato DJ, Lovejoy JF, Agrawal S, et al. Postoperative ketorolac does not predispose to pseudoarthrosis following posterior spinal fusion and instrumentation for adolescent idiopathic scoliosis. Spine 2008;33:1119–24. 13. Suk SI, Lee CK, Kim WJ, et al. Adding posterior lumbar interbody fusion to pedicle screw fixation and posterolateral fusion after decompression in spondylolytic spondylolisthesis. Spine 1997;22:210–9; discussion 219-220.

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